Careers

Careers

Mission

At Flowonix, our patient centric approach drives the design, development, and deployment of targeted drug delivery platforms whose sole purpose is to provide physicians an optimal solution for the treatment of their patients' numerous neurological disorders.

Core Values

  • Character – The common thread of our culture. One is never wrong doing what is right.
  • Integrity – Saying exactly what we mean and doing what we say.
  • Relentless – While never at the expense of progress, we push for perfection.
  • Purpose – Optimizing patient outcomes is our greater cause.

 

It's the desire to help people with life-changing technology that drives every member of the Flowonix team. At Flowonix we believe our employees are an essential component to our long-term success, and it is this mindset that drives our commitment to offer unique career opportunities.

We are passionate about having a diverse and talented workforce to solve the big problems we are seeking to tackle. We offer a competitive health and benefits package.

Browse our current job openings below. If you do not see any current openings but are interested in joining our team, please feel free to send an email to jobs@flowonix.com 

Technical Solutions Engineer

Position Title: Technical Solutions Engineer

Reports to: Director, Field Support

Department: Customer Care

Location: Mt. Olive, NJ

 


 

Accountability Objective: 

Responsible for documenting and resolving technical issues received from customers and field representatives as well as coordinating and supporting multiple cross-functional in-house teams including sales education and training.

Essential Functions:

  • Address questions from customers and patients about Flowonix products.
  • Develop a strong working relationship with all members of the field engineering and Sales force.
  • Ensure that technical service issues are well documented and resolved in a timely manner.
  • Interface with complaint coordinator to ensure complaints are properly documented.
  • Share clinical/technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customers.
  • Coordinate and support in-house educational activities as requested by members of the team.
  • Participate in weeknight and weekend on-call support rotation.

Decision Making Authority:

  • Document and resolve all technical issues. Identify training needs and support materials in cooperation with other team members.

Position Specifications:

  • Knowledge/Educational Requirements: 
    • Bachelor'r or graduate degree in engineering
    • 3-4 years of experience implanting and following similiar medical devices
    • Strong working knowledge of how the devices work, from an engineering perspective
    • Excellent working knowledge of industry best practices for best-in-class customer service in a technical support environment
  • Skills and Abilities:
    • Highly flexible - able to adapt to changing business needs
    • Solutions oriented - self-driven and analytical to provide potential solutions as new problems arise
    • "Builder" mentality - individual who takes ownershp and desires to continue to improve processes and workflows
    • Well rounded engineer who can understand both technical details and big picture scenarios, then communicate with multiple types of colleagues
    • Ability to communicate with others, including verbal, written, and electronic communication
    • Ability to quickly analyze and resolve clinical/technical issues
    • Ability to work effectively under pressure in a fast-paced, time sensitive environment with shifting priorities and multiple deadlines
    • Strong interpersonal, communication and analytical skills
  • Physical Demands/Work Environment:
    • Office-based responsibilities with occasional travel as necessary to support education activities
    • Ability to maintain on-call servicing

Positions Supervised:

Direct Reports - None

Indirect Reports - None

Working Relationships:

Internal Contacts - All personnel associated with field-based activities, R&D personnel, Regulatory Affairs and specialists.

External Contacts - Site personnel including; physicians, research coordinators, and oter support staff. Patients calling with questions about Flowonix Medical products.

 

Please Click below to submit your resume to this position opening:

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Sr. Regulatory Affairs Specialist

Position Title: Sr. Regulatory Affairs Specialist

Reports to: Director of Regulatory Affairs

Department: Regulatory Affairs

Location: Mt. Olive or Mansfield, MA

 


 

Accountability Objective: 

Responsible for the completion of assigned US and OUS Regulatory Submissions for new and existing products marketed by Flowonix Medical; assure compliance with US and OUS International regulatory requirements for Class III (US) and Active Implantable Medical Devices (EU).

Essential Functions:

  • Responsible for managing the compliance with reporting requirements related to US and OUS approvals such as MDRs, Vigilance Reporting, Post Approval Study Reports, Progress Reports and reports related to IDE and PMA approvals.
  • Responsible for the preparation of OUS regulatory submissions in order to maintain the design dossier and compliance to the essential requirements for CE marking.
  • Responsible for supporting ongoing manufacturing related to regulatory affairs, such as reviewing nonconforming material reports, engineering change notices, verification and validation protocols and reports, corrective and preventative actions and compliance with regulatory approvals and internal procedures.
  • Support regulatory involvement in the overall compliance program to meet the medical device requirements of FDA and international agencies pertaining to marketing, manufacturing, quality, and product surveillance.
  • Participate in cross functional product development teams on behalf of Regulatory Affairs and Flowonix Medical. Identify and help resolve product development issues which relate to regulatory submission activities. Coach technical activities to achieve compliance with essential requirements (e.g., design control, design validation).
  • Participate in overall document management strategies which support the device history file required by FDA regulations and product design dossier required by OUS for obtaining a design examination certificate. 
  • Support ongoing activities within other departments, carry out departmental administrative duties and other duties as assigned.

Decision Making Authority:

  • Provide guidance for internal staff on regulatory and engineering matters.
  • Assigned tasks related to US and OUS regulatory submissions to support product approvals.

Position Specifications:

  • Knowledge/Educational Requirements- Minimum of Bachelors level degree with 4 years in medical device regulatory affairs; experience with U.S. and/or E.U. submissions is required. Experience with Class III medical device submissions and/or E.U. MDD/AIMD is desirable. Experience with MDR/Vigilance reporting is desirable; excellent working knowledge of US (QSR) and OUS Quality System requirements (ISO-13485) and requirements to obtain and maintain medical device marketing approvals is required.
  • Communication/Language Skills - Must be able to effectively and persuasively communicate in English language, both verbally and in writing; must be able to read and understand scientific literature and clinical articles. Prior publication experience desirable.
  • Computer/Software Literacy - Proficient with Microsoft Office Suite of software applications, especially Word, Excel, Powerpoint and Outlook; electronic submissions require expert knowledge of Adobe Acrobat 8.0 or later. Working knowledge of Microsoft Visio, Adobe Photoshop, and other document creation tools (e.g., scanning) desirable. Must be able to conduct effective research using web-based search tools and databases.
  • Technical/Problem Solving Skills - Organized with excellent technical, analytical and problem-solving abilities; strong interpersonal skills, project management and team participation skills required.
  • Physical Demands/Work Environment - Office environment, heavy PC usage; travel required up to 25% (domestic and international).

Positions Supervised:

Direct Reports - None

Indirect Reports - Administrative Staff

Working Relationships:

Internal Contacts - Heavy cross-functional contact with all departments

External Contacts - Consultants and suppliers.

 

Please Click below to submit your resume to this position opening:

APPLY HERE